Friday, 24 September 2010

Despite evidence that oral cladribine is effective in relapsing-remitting MS the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a negative opinion regarding the marketing authorization for Cladribine Tablets. The CHMP have concerns about the long-term safety of Cladribine.

In my opinion, long-term safety data can only be obtained from post-marketing surveillance studies and the extension study of the pivotal clinical trial. Unfortunately, there are probably not enough patients in the latter study to answer this question. It is a good thing that the drug is licensed in Russia and Australia.

Wednesday, 22 September 2010

The FDA has licensed Fingolimod as a first-line therapy for people with relapsing-remitting MS. Let's hope it passes through the European Medicine Agency (EMA) with the same ease as the FDA and NICE gives it the thumbs up in the UK; the pessimist in me expects not. I predict that its use will be handcuffed in Europe for patients with highly-active disease (similar to Natalizumab) and for patients intolerant of first-line injectable therapies. I also suspect NICE will make it second-line; however this will depend on how much Novartis charge for the drug.

Wednesday, 8 September 2010

Apologies about politicising this blog, but what happens to investment in science in the UK will eventually impact on the lives of people with MS and their families. The only way to limit the impact of this devastating disease is through scientific research. The unmet need in MS is massive:

1. We have yet to optimise disease-modifying therapies. Is expecting a cure too much?
2. What about restorative therapies?
3. Symptomatic MS therapies are dismal; too many side effects and limited or suboptimal efficacy.
4. What about prevention? Preventative strategies are just beginning to emerge as potential option.

Without investment in research how are we going to address these needs?

Sunday, 5 September 2010

Different types of inflammation are defined by immunologists by the type of cells and the mediators used by these cells.

The current dogma: inflammation in MS is mediated by either T-helper one (Th1) or T-helper 17 (Th17) cells. In comparison, allergies are due to a T-helper two (Th2) immune response, which may be protective in MS.

A large analysis of all published studies on allergic disease and MS provides no evidence of a positive or negative association between the allergic diseases asthma , allergic rhinitis and eczema.

Implications: this analysis challenges the current dogma and also raises questions about the treatment strategy of trying to stimulate Th2 immunity in PwMS; e.g. by promoting parasitic infections of the gut.

Thursday, 2 September 2010

A study in 80 PwMS was performed to evaluate the effect of 8 weeks of treatment with LDN (4.5mg taken at night). Although LDN was associated with significant improvement in some mental health quality of life measures, the trial was too small to draw definitive conclusions.

Interpretation: this study was too small to be definitive. However, it provides further support for a large definitive study of LDN in MS. Unfortunately, the current "Big Pharma" business model does not support investigating drugs that are off patent. May be "Big Pharma" will now try and develop a follow-on me-to drug to test in PwMS.

PML Risk Infographic

Holistic Management of MS ver. 7.0

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